The present invention relates to an apparatus and method for delivering and deploying an expandable body member in a uterine cavity. More particularly, the present invention is directed to an apparatus and method for delivering and deploying an expandable body member in the uterine cavity so that contact of the endometrial layer in the uterine cavity and the surface of the expandable body member in an expanded state is maximized.
Ablation is a medical procedure which may be performed to treat one of many conditions such as abnormal bleeding of the endometrial layer of the uterus. To perform an ablation procedure, many types of ablation devices have been developed.
U.S. Pat. No. 5,769,880 to Truckai et al. teaches an apparatus and method for performing ablation of organs. The ablation apparatus includes an electrode carrying member that is mounted to a distal end of an elongated shaft. An array of electrodes is mounted to the surface of the electrode carrying member. After placement of the ablation apparatus in contact with the tissue to be ablated, a radio frequency generator is used to deliver radio frequency energy to the electrodes to induce current flow from the electrodes to the tissue to be ablated. The electrode carrying member is fabricated from a material which is, preferably, nonconductive, permeable to moisture, moisture absorbable and compressible. The electrode carrying member can be compressed to a smaller volume and subsequently released to its natural size upon elimination of the compression. Preferred materials for the electrode carrying member include open-cell sponge, foam, cotton, fabric, cotton-like material or any other material having the above-described characteristics.
U.S. Pat. No. 5,484,426 to Yoon teaches a multifunctional device used in endoscopic surgical procedures. The multifunctional device includes sponge material that is formed with a specific configuration to conform to a cavity wall to be cauterized. The multifunctional device also includes a tubular electrically conductive trunk with electrically conductive solid or tubular branches extending angularly therefrom which terminate at the peripheral surface of the sponge material when the sponge material is in a wet state. An electro-surgical probe is passed through the tubular trunk so that a unipolar electro-surgical device is produced with multiple electrodes defined at a peripheral surface of the sponge material. The multifunctional device is utilized to ablate or coagulate surface areas such as cystic cavities or the endometrium of a uterus.
In a non-pregnancy state, the uterus has a uterine cavity analogous to a freshly-ironed shirt pocket. In other words, opposing surfaces of the endometrial layer defining the uterine cavity contact each other in a facially opposing relationship thereby eliminating any useful space for performing ablation procedures. Thus, most ablation devices that are designed for insertion into the uterine cavity must create useful space therein. Particularly, it is beneficial that the portion of the ablation device inserted into the uterine cavity makes substantial contact with the endometrial layer. Particularly, with ablation devices using expandable body members such as the ones described above, expansion of the body member to its expanded state might not adequately expand the uterine cavity. Thus, contact between the endometrial layer and the surface of the expandable body member might be insufficient.
It is an object of the present invention to provide an apparatus and method for delivering an expandable body member into a uterine cavity of a uterus and deploying the expandable body member in the uterine cavity.
It is another object of the invention to provide an apparatus and method for delivering an expandable body member into the uterine cavity of the uterus and deploying the expandable body member in the uterine cavity such that contact between the endometrial layer and an expanded body member surface of the expandable body member in the expanded state is maximized.
Accordingly, an apparatus and method for delivering an expandable body member into a uterine cavity and deploying the expandable body member from its compressed state to its expanded state are hereinafter described. The apparatus of the invention delivers the expandable body member in a compressed state through the cervical opening and into the uterine cavity of a living body and deploys the expandable body member from the compressed state to the expanded state while the expandable body member is disposed in the uterine cavity. The apparatus includes an elongated tubular member and a fluid-providing device. The elongated tubular member has a distal portion, a proximal portion and an intermediate portion disposed between the distal portion and the proximal portion. The expandable body member is connected to the distal portion. The fluid-providing device is connected to the proximal portion of the elongated tubular member. The fluid-providing device is operative to provide a fluid to the uterine cavity through the elongated tubular member at a sufficient pressure to inflate the uterine cavity to a volume larger than the expandable body member in the expanded state. The provided fluid also causes the expandable body member to expand from the compressed state to the expanded state.
The method of the invention delivers the expandable body member into the uterine cavity of the uterus through a cervical opening and deploys the expandable body member in the uterine cavity which is defined by the endometrial layer. The expandable body member expands from a compressed state to an expanded state to form an expanded body member surface. One step of the method of the present invention is inserting the expandable body member in the compressed state through the cervical opening and into the uterine cavity. Another step provides a fluid to the uterine cavity at a pressure sufficient to inflate the uterine cavity. Another step causes the expandable body member to expand from the compressed state to the expanded state. Another step relieves the fluid pressure thereby allowing the uterine cavity to collapse about the expandable body member in the expanded state so that the endometrial layer and the expanded body surface substantially contact each other in a facially opposing relationship.
Other objects and advantages of the present invention will become apparent from the following description of the embodiments taken in conjunction with the accompanying drawings.